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Immunocap Allergen K82

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121463

by Thermo Fisher Scientific

Identifiers

510(k) Number
K121463 FDA 510(k)
FDA Product Code
DHB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5750 FDA 510(k)
Regulation Number
866.5750 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ImmunoCAP Allergen K82 Latex is a System, Test, Radioallergosorbent (RAST) Immunological device designed for the in vitro quantification of specific Immunoglobulin E (IgE) antibodies in human serum or plasma. It employs a solid-phase allergen immunoassay to detect IgE-mediated sensitization to latex allergens, aiding in the diagnosis of allergic conditions.

This device is supplied as a single-use diagnostic reagent kit and is intended for use in clinical immunology laboratories. It requires storage under controlled conditions as specified in the accompanying documentation, with no MRI safety considerations noted. Authorized for use in the United States under FDA 510(k) clearance (K121463), the ImmunoCAP Allergen K82 Latex adheres to regulatory standards for Class II medical devices (DHB product code)

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ImmunoCAP Allergen k82, Latex - Thermo Fisher Scientific, Thermo Scientific ImmunoCAP Occupational Allergens k82 - Fisher Sci, Thermo Scientific ImmunoCAP Occupational Allergens k82 - Fisher Sci

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Thermo Fisher Scientific

Sources (1)

  • FDA 510(k) K121463 24 fields · synced Sep 19, 2026